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Clinical Trial Summary

This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.


Clinical Trial Description

Enrolled subjects will receive three (3) face and/or neck treatments provided 30 days apart. During each treatment subjects will receive both Infini and LaseMD treatments. Treatments will be provided according to a protocol-specific treatment protocol in which an Infini treatment will be provided first, followed by a LaseMD treatment. A telephone contact will be completed at 3 days following each treatment to assess for adverse events. One follow-up visit will be conducted at 90 days following the last study treatment. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photographs and D90 study photographs will be obtained. ;


Study Design


Related Conditions & MeSH terms

  • Face and Neck Wrinkles, Texture, Pigmentation

NCT number NCT03409965
Study type Interventional
Source LUTRONIC Corporation
Contact
Status Completed
Phase N/A
Start date December 8, 2017
Completion date August 21, 2018